EUCTR2018-003921-27-ES进行中（未招募）1 期
Doravirine concentrations and antiviral activity in genital fluids in HIV-1 infected individuals. - DORAGE
luita contra la SIDA Foundation0 个研究点目标入组 30 人开始时间: 2019年4月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Asymptomatic, HIV-1 infected individuals = 18 years of age.
- •2. Be on a stable ART consisting of TAF/FTC, tenofovir disoproxil fumarate/emtricitabine or abacavir/lamivudina, plus an non-nucleoside reverse transcriptase inhibitor, a boosted protease inhibitor or an integrase inhibitor, continously for at least 3 consecutive months preceding the screening visit.
- •3. Plasma HIV-1 RNA <40 copies/mL for at least 6 months at the Screening visit.
- •4. Signed and dated written informed consent prior to inclusion.
- •5. Subjects must agree to utilize a highly effective* method of contraception during heterosexual intercourse from the screening visit throughout the duration of the study
- •(*) Highly effective methods of contraception as defined by the Clinical Trial Facilitation Group (CTFG) (Recommendations related to contraception and pregnancy testing in clinical trials”, version 15/09/2014): 1. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); 2. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); 3. Intrauterine device (IUD); 4. Intrauterine hormone-releasing system (IUS); 5. Bilateral tubal occlusion; 6. Vasectomised partner; 7. Sexual abstinence.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Severe hepatic impairment (Child-Pugh Class C)
- •2. Ongoing malignancy
- •3. Active opportunistic infection
- •4. Primary resistance to any of the ARV included in the study or history of virologic failure with risk of resistance selection to any of the study drugs.
- •5. Any verified Grade 4 laboratory abnormality
- •6. ALT or AST = 3xULN and/or bilirubin = 1.5xULN
- •7. Severe renal impairment (Estimated creatinine filtration rate <50mL/min).
- •8. Females who are pregnant (as confirmed by positive serum pregnancy test) or breastfeeding.
研究者
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